Ventyx Biosciences discovered that even a seemingly successful clinical trial may not be enough to support a drug’s advancement, as they reviewed data from a phase 2 trial of the TYK2 inhibitor VTX958 for moderate to severe plaque psoriasis. The study showed that the two higher doses, 225 mg and 300 mg, out of the four assessed, met the primary endpoint by demonstrating a statistically significant proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index at Week 16 compared to a placebo.
However, upon closer examination, Ventyx determined that the observed efficacy did not meet their internal target to support the progression of VTX958 in plaque psoriasis. Consequently, the company is discontinuing both its phase 2 plaque psoriasis trial and a separate midstage study of the drug in psoriatic arthritis. A further phase 2 trial of VTX958 in Crohn’s disease will continue to enroll patients for now, with an interim efficacy analysis planned for the first quarter of the coming year.
The announcement had a negative impact on Ventyx’s stock, causing it to plummet by 73% in premarket trading, from $14.09 to $3.77.
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“While the Phase 2 trial of VTX958 in plaque psoriasis met the primary and key secondary endpoints, we are disappointed by the magnitude of efficacy observed, despite having achieved target levels of drug exposure in the trial. Although these results do not support further development of VTX958 in the highly competitive psoriasis and psoriatic arthritis indications, I want to thank the patients and investigators for their participation. I would also like to thank the Ventyx team for their diligence and dedication in executing these trials.”
– Raju Mohan, Ph.D., Founder and Chief Executive Officer
Despite this setback, Ventyx has three other candidates in clinical trials, including VTX002, a S1P1R modulator that demonstrated positive results in a phase 2 trial for ulcerative colitis. Another candidate, VTX2735, a peripheral NLRP3 inhibitor, is currently undergoing midstage trials for patients with familial cold autoinflammatory syndrome.
VTX002 faced a similar challenge as VTX958, achieving the primary endpoint in a phase 2 trial but leaving investors uncertain about its competitive edge compared to other S1P1 modulators like Pfizer’s etrasimod and Bristol Myers Squibb’s approved Zeposia.